Research Involving Private Information or Biospecimens

Are the biospecimens/information obtained from living individuals?

NO, individuals
NOT are NOT
Human Subjects living
Research YES, individuals ARE living

NOT Human Subjects Research Are the biospecimens/information:

 Human cell lines obtained from a commercial provider (e.g. ATCC); or
 Human cells about which all information has been published; or
 Unidentifiable biospecimens/information obtained from a commercial provider; or
 Unidentifiable biospecimens/information obtained from a provider that is
prohibited from releasing identifiers by established regulations or policies

NO YES

Were/will the biospecimens/information (be) collected specifically for the NOT Human Subjects Research
proposed research through an interaction or intervention with living individuals?

NO YES

Can the recipient link the biospecimens/information directly to Human Subjects Research
identifiable private information of living individuals?

NO YES

Can the provider link the biospecimens/information directly to Human Subjects Research
identifiable private information of living individuals?

NO YES

NOT Human Subjects Research Does the provider meet the definition of an “investigator” in the recipient’s research?

NO, the provider is “solely providing” YES, the provider is collaborating in the recipient’s research

Are the biospecimens/information provided with a code linking Human Subjects Research
them to identifiable private information of living individuals?

NO YES

NOT Human Subjects Research
Can the recipient readily ascertain the identities of the individuals to whom the
biospecimens/information pertain? Examples of situations in which the recipient cannot
link the biospecimens/information to living individuals include:
 the key to decipher the code is destroyed before the research begins; or
 the investigators and the holder of the key to the code enter into an agreement
preventing the release of the key to investigators under any circumstances; or
 there are IRB-approved written policies in place preventing the release of the key
under any circumstances; or
 there are other legal requirements prohibiting the release of the key under any
circumstances.

NO YES

NOT Human Subjects Research Human Subjects Research

Please note: this document is intended to be a resource only. Final decisions should be made in accordance with 45 CFR 46.
NIH Office of Extramural Research - June 25, 2019